AccessGUDID - DEVICE: Medichoice (10885632106002)

GUDID

Device Identifier (DI) Information

Brand Name: Medichoice
Version or Model: 916812A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632106002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Kit Thermometer Digital Oral Dual-Scale Blue Cap With 20 Sheaths Not Made With Natural Rubber Latex MediChoice

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14025	Thermometer kit	A collection of devices intended to be used to eliminate the reprocessing, reduce the risk of breakage and cross-contamination, and reduce the variance caused by the use of more than one thermometer per patient. It typically includes a thermometer [e.g., a mercury (Hg) or alcohol thermometer] for measuring human body temperature; and other components such as holders, cases, vials, or sheaths. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, electronic, clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify:
Special Storage Condition, Specify: Do not Store in direct sunlight or extreme heat
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 800 and 1060 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a278dc64-e59d-4722-8a42-1eddc0fbdd90
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 20, 2016